Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the absence of records and interview with TP(testing personnel) 9/12/18, the laboratory failed to enroll in proficiency testing for blood gas (pH, pO2, pCO2), creatinine, glucose, sodium, potassium, lactate, and hematocrit testing. Based on the absence of records, the laboratory failed to enroll in proficiency testing for the following analytes tested on the epoc Blood Analysis System: blood gas (pH, pO2, pCO2); calcium; creatinine; glucose; sodium; potassium; lactate; hematocrit. During interview at approximately 11:20 a.m., TP #1 confirmed that the laboratory was not enrolled in proficiency testing. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on review of 2016, 2017, and 2018 epoc blood gas quality control records and interview with TP (testing personnel) 9/12/18, the laboratory failed to retain all quality control records for at least two years. Review of quality control records for the epoc blood analysis system revealed the laboratory did not have the VAD (Value Assignment Datasheet) available for the following quality control lot numbers: 1. Eurotrol GAS-ISE Metabolites Level 1 lot #179-1-B546 (Sensor Configuration 27.1 and 28.4); 2. Eurotrol GAS-ISE Metabolites Level 3 lot #179-3-B547 (Sensor Configuration 27.1 and 28.4). During interview at approximately 1:10 p.m., TP #1 stated this lot number was used before she was hired, so she was unsure where the VADs might be if they were not with the other records. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)